Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 008845
Company: HOSPIRA
Company: HOSPIRA
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| QUELICIN | SUCCINYLCHOLINE CHLORIDE | 20MG/ML | INJECTABLE;INJECTION | Prescription | AP | Yes | Yes |
| QUELICIN PRESERVATIVE FREE | SUCCINYLCHOLINE CHLORIDE | 20MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE;INJECTION | Discontinued | None | Yes | No |
| QUELICIN PRESERVATIVE FREE | SUCCINYLCHOLINE CHLORIDE | 50MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE;INJECTION | Discontinued | None | Yes | No |
| QUELICIN PRESERVATIVE FREE | SUCCINYLCHOLINE CHLORIDE | 100MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE;INJECTION | Discontinued | None | Yes | No |
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
|---|---|---|---|---|---|
| 11/01/2022 | SUPPL-80 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/008845s080lbl.pdf | |
| 02/17/2022 | SUPPL-79 | Labeling-Container/Carton Labels | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/008845Orig1s079lbl.pdf | |
| 08/11/2021 | SUPPL-76 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/008845s076lbl.pdf | |
| 07/26/2018 | SUPPL-73 | Labeling-Container/Carton Labels | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/008845s073lbl.pdf | |
| 07/26/2018 | SUPPL-73 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/008845s073lbl.pdf | |
| 11/22/2010 | SUPPL-65 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/008845s065lbl.pdf |